Sudden shift in enforcement focus creates significant risks for personal care and cosmetics companies, among others
This year has seen a sharp rise in the number of Prop 65 notices of violation (NOVs) issued for diethanolamine (DEA), which has been listed as a carcinogen under Prop 65 since 2012 but with little enforcement activity until now. Between 2013 and 2023, an average of 26 NOVs for DEA were reported per year to the California Office of the Attorney General, for a total of 289 over the ten-year period. So far in 2024, there have already been over 300 NOVs issued for DEA.
To date, NOVs for DEA have primarily been issued for personal care products, including lotions, sunscreens, shampoos, and gels, and for cosmetics, including mascara, eyeliner, and foundation.
Prop 65, formally known as the Safe Drinking Water and Toxic Enforcement Act of 1986, requires companies to provide warnings before exposing consumers to chemicals known to the State of California to cause cancer or reproductive/developmental effects if those exposures exceed chemical-specific safe harbor levels (SHLs). The California Office of Environmental Health Hazard Assessment (OEHHA) develops Prop 65 SHLs that include no significant risk levels (NSRLs) for carcinogens and maximum allowable dose levels (MADLs) for reproductive and developmental toxicants. To date, OEHHA has not published an NSRL for DEA; however, potential NSRLs have been proposed in the scientific literature.
Under Prop 65, an NOV must be served at least 60 days before a lawsuit can be filed. However, filing an NOV does not require demonstrating that typical use of the product results in exposures above the SHLs and, thus, may require a Prop 65 warning. Most NOVs allege only that a Prop 65 listed chemical is present in the product and that there is not a "clear or reasonable" warning.
Assessing products containing DEA for compliance with Prop 65
The only way to determine whether typical product use might result in significant exposures to DEA requiring a Prop 65 warning is to conduct product testing and exposure assessments. While DEA can be added intentionally, it can also be unintentionally present as a low-level contaminant when it is used to produce diethanolamides or as an impurity of triethanolamines (TEA). These are common ingredients in personal care products like shampoos, cosmetics, and other products to add a foamy and creamy texture. Analytical testing is necessary to confirm whether DEA is present in the final product and, if so, the amount (i.e., concentration) of DEA present.
Importantly, the presence of DEA alone does not mean there is significant exposure that may require a warning under Prop 65. Instead, conducting an exposure assessment is necessary to determine whether typical use of the product could result in significant exposure to the amount of DEA present in the product. In the absence of an OEHHA-published NSRL for DEA, assessments of DEA require businesses to identify an exposure level posing no significant risk as defined by Prop 65.
Doing your DEA due diligence under Prop 65
Given the uptick in enforcement actions and low threshold for filing an NOV, it is important to understand what is in your product by doing your due diligence. Even if you completed a Proposition 65 evaluation for DEA in the past, testing methodologies have improved over time, so it is important to have recent analytical testing. It is also important to understand how consumers use your product, since the potential for exposure associated with a product depends on the nature of the consumer's interaction with the product. With no SHLs established by OEHHA for DEA, companies are required to show that the anticipated exposure level will not pose significant risk of cancer as defined by Prop 65.
Understand and mitigate your risks for DEA under Prop 65 by:
- Ensuring compliance with Proposition 65 regulations
- Reviewing your product formulations to determine whether your product contains DEA or ingredients like diethanolamides and TEA, which may contain low levels of DEA as a contaminant
- Conducting thorough exposure assessments
- Determining the potential DEA exposure level based on available testing results and exposure assessments
- Identifying threshold level (i.e., NSRL) where the exposure is low enough to pose no significant cancer risk
- Maintaining up-to-date quality assurance programs with appropriately sensitive analytical testing
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